Z-0062-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2017
- Initiation Date
- September 25, 2017
- Termination Date
- August 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1148189 units
Product Description
CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).
Reason for Recall
Smiths Medical became aware that certain Non Flow-Stop CADD(R) Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate.
Distribution Pattern
Worldwide Distribution - US (nationwide) Internationally to Czech Republic, Lebanon, United Arab Republic, Austria, Australia, Belgium, Bermuda, Canada, Switzerland, Chile, Colombia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Indonesia, Ireland, Italy, Luxembourg, Netherlands, Japan, Norway, Portugal, Saudi Arabia, Sweden, Belgium, Switzerland, Spain, China, Estonia, Hong Kong, Omen, Indonesia, Puerto Rico, Hungary, Israel, Singapore, Santa Domingo, New Zealand, Philippines, South Africa, Malaysia, and Lebanon
Code Information
All lot numbers